Инструкция по применению KORUM
Содержание инструкции
Corhum solution for cardioplegia
Read this leaflet carefully before using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What Corhum solution for cardioplegia is and what it is used for
- 2. What you need to know before using Corhum solution for cardioplegia
- 3. How to use Corhum solution for cardioplegia
- 4. Possible side effects
- 5. How to store Corhum solution for cardioplegia
- 6. Contents of the pack and other information
1. What is Corhum solution for cardioplegia and what is it used for
Corhum solution for cardioplegia is a mixture of electrolytes and amino acids.
Corhum solution for cardioplegia is used:
- in cases of artificially induced and reversible cardiac arrest in open-heart surgery (cardioplegia in cardiac surgery) through a change in electrolyte balance.
2. What you need to know before using Corhum solution for cardioplegia
Corhum solution for cardioplegia must be used only during surgical procedures.
Do not use Corhum solution for cardioplegia
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsConsult your doctor before using Corhum solution for cardioplegia. Inform your doctor if you are pregnant, as this will affect the use of the solution. For safety reasons, in the event of emergency cardiac surgery during pregnancy, the doctor will aspirate the perfusion solution from the right atrium and ventricle of the heart after completing the operation.
Corhum solution for cardioplegia is not indicated for intravenous administration, but only for
perfusion during cardiac arrest. Therefore, Corhum solution for cardioplegia must not be
used for systemic infusion.
Depending on the type of surgical procedure, the method used, the duration of the procedure and the
patient's weight, up to 3 liters of perfusion solution can enter the entire circulatory
system. This may lead to a decrease in blood levels of calcium and sodium. The doctor
will then perform appropriate laboratory tests.
Children and adolescents
Clinical studies have not been conducted on children and adolescents, but it can be used if the doctor
considers it necessary.
Other medicines and Corhum solution for cardioplegia
Tell your doctor if you are taking, have recently taken or used, or might take
or use any other medicine.
No interactions are known with the following medicines commonly used during, but often also
before and after surgery:
- certain medicines for the treatment of heart failure (cardiac glycosides)
- diuretics (diuretics)
- medicines for the treatment of angina pectoris symptoms (e.g. chest pain or tightness).
- medicines used in conditions of insufficient oxygen supply to the heart muscle (such as nitrate derivatives, beta-blockers or calcium antagonists)
- antihypertensive drugs (e.g. beta-blockers or calcium channel blockers).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
Corhum solution for cardioplegia should be used during pregnancy and breastfeeding only
after carefully evaluating the benefit/risk ratio (see also Warnings and
precautions).
Driving and operating machinery
Corhum solution for cardioplegia does not impair the ability to drive vehicles and operate machinery.
Corhum solution for cardioplegia contains sodium and potassium
Corhum solution for cardioplegia contains 345 mg of sodium (the main component of table/cooking salt) per 1000 ml.
This corresponds to 17% of the maximum recommended daily intake of sodium for an
adult.
Corhum solution for cardioplegia contains 352 mg of potassium per 1000 ml. To be taken into
consideration in patients with reduced kidney function or in patients following a low-potassium diet.
3. How to use Corhum solution for cardioplegia
The treatment regimen and dose must be established by a specialist. Corhum solution for
cardioplegia must only be administered by a healthcare professional, i.e., a doctor or a
nurse.
If more Corhum solution for cardioplegia has been used than prescribed
Absorption of large quantities of Corhum solution for cardioplegia into the circulation can
lead to volume overload and electrolyte imbalances (levels too low of calcium or sodium
in the blood or levels too high of magnesium and potassium in the blood). In such cases, the doctor
will perform periodic blood tests.
Note for the doctor: further information on overdose is reported at the end of this
If you have any doubts about the use of this medicine, please consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with frequency not known (cannot be estimated from available data):
The use of Corhum solution for cardioplegia may lead to a temporary reduction in
blood pressure during surgery.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Corhum cardioplegia solution
Store in a refrigerator (2 °C – 8 °C) and keep the bag in the outer packaging to protect the
medicinal product from light.
Do not freeze. After opening, use immediately.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The
expiry date refers to the last day of that month.
Medicinal product that is not used and waste derived from such medicinal product must be disposed of in
accordance with current local regulations. These measures will help to protect the environment.
6. Package contents and other information
What Corhum cardioplegia solution contains
The active ingredients are:
1000 ml of solution contains
0.8766 g Sodium chloride 15.0 mmol
0.6710 g Potassium chloride 9.0 mmol
0.8132 g Magnesium chloride hexahydrate 4.0 mmol
3.7733 g Histidine hydrochloride monohydrate 18.0 mmol
27.9289 g Histidine 180.0 mmol
0.4085 g Tryptophan 2.0 mmol
5.4651 g Mannitol 30.0 mmol
0.0022 g Calcium chloride dihydrate 0.015 mmol
0.1461 g 2-oxoglutaric acid 1.0 mmol
The excipients are water for injections and potassium hydroxide (to adjust the pH)
nitrogen.
Description of the appearance of Corhum cardioplegia solution and contents of the pack
Use only if the solution is clear, from colorless to slightly straw-yellow, in containers
that are not damaged.
For single use only. Unused residues must be discarded.
Corhum cardioplegia solution is available in bags of 1000 ml and 2000 ml (polyolefin/styrene block copolymer) with two tubes (polyolefin/styrene block copolymer) sealed with a perforable stopper made of polyisoprene with silicate filler and polycarbonate and a chlorobutyl injection stopper. The
bags are packaged inside an overwrap in polypropylene to ensure external sterility
of the primary bag.
Pack sizes:
Cardboard box with 10 bags of 1000 ml.
Cardboard box with 5 bags of 2000 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder :
S.A.L.F. SpA Laboratorio Farmacologico
Via G. Marconi, 2
24069 Cenate Sotto (Bergamo)
Italy
Manufacturer:
S.A.L.F. SpA Laboratorio Farmacologico
Via G. Mazzini 9
24069 Cenate Sotto (Bergamo)
Italy
This medicinal product is authorised in the Member States of the European Economic Areaand in the
United Kingdom (Northern Ireland) with the following denominations:
Austria Corhum Kardioplege Lösung
Denmark Corhum
Finland Corhum solution for cardioprotection
Italy Corhum cardioplegia solution
Norway Corhum solution for cardioplegia
United Kingdom (Northern Ireland) Corhum solution for cardioplegia
Spain Corhum solution for cardioplegia
Sweden Corhum, solution for cardioplegia
The following information is intended exclusively for healthcare professionals:
Special warnings and precautions for use
Complete inactivation makes the myocardium sensitive to dilation. It is therefore important to ensure
adequate drainage of the ventricle. Do not exceed the recommended perfusion volumes and pressures.
Pay particular attention to the hearts of children and infants.
Inadequate perfusion with cardioplegic solution that is not sufficiently cooled (>20°C and
>15 minutes) can cause the so-called "calcium paradox" and lead to the destruction of myocardial cells
once the organ is implanted.
This risk does not apply to solutions with a sodium content <20 mmol/l, if the calcium content is > 10 μmol/l and if the solution is cold, i.e. <15°C, and is perfused continuously for a
limited period of no more than 20 minutes.
Immersing an entire heart in cold Corhum cardioplegia solution, however, does not
pose a risk in terms of calcium paradox even when carried out for hours – e.g.
for the time between the organ being removed from the donor and transplantation into the recipient. Therefore,
with correct use, the calcium paradox is practically impossible even under
extreme experimental conditions.
Overdosage
Passing large volumes of Corhum cardioplegia solution into the systemic circulation
can lead to volume overload and electrolyte imbalances (hypocalcemia, hyponatremia,
hypermagnesemia, hyperkalemia). After systemic administration, regular monitoring of serum electrolytes is recommended.
Incompatibilities
In the absence of compatibility studies, Corhum cardioplegia solution must not be mixed
with other medicinal products.
- Страна регистрации
- Форма выпускаOrgan preservation solution, 1000 ML
- Код АТХB05XA16
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KORUMФорма выпуска: Organ preservation solution, 500 MLДействующее вещество: cardioplegia solutionsПроизводитель: DR. FRANZ KOHLER CHEMIE GMBHОтпускается по рецептуФорма выпуска: Irrigation solution, 495 ML + 10 MLДействующее вещество: cardioplegia solutionsПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается без рецептаФорма выпуска: Organ preservation solution, 20 MLДействующее вещество: cardioplegia solutionsПроизводитель: MONICO S.P.A.Отпускается по рецепту
Аналоги KORUM в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог KORUM в Испания
Аналог KORUM в Польша
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
KORUM не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KORUM — cardioplegia solutions. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KORUM производится компанией S.A.L.F. SPA LABORATORIO FARMACOLOGICO. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения KORUM с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить KORUM в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (cardioplegia solutions) включают KUSTODIOL, SOLUTSIONE KARDIOPLEJIKA GALENIKA SENESE, SOLUTSIONE KARDIOPLEJIKA MONIKO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















